Food and Drug Administration: Revenue Information on Certain Companies Participating in the Medical Device User Fee Program

Randall B. Williamson

08.2007 г. · DIANE Publishing

Всичко за тази електронна книга

The Food & Drug Amin. (FDA) is responsible for approving medical devices -- such as catheters & artificial hearts -- to provide reasonable assurance of their safety & effectiveness. Congress enacted the Medical Device User Fee & Modernization Act of 2002 (MDUFMA) which authorizes FDA to charge user fees for some device applications & not others. In FY2005, FDA collected $31 million in user fees from device applications. This report provides revenue information for: (1) companies that qualified as small businesses under the MDUFMA user fee program in FY2006; & (2) companies publicly traded in the U.S. that submitted device applications subject to user fees & did not qualify as small businesses under MDUFMA in FY2006. Charts.